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The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

• degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
• spondylolisthesis
• trauma (i. e., fracture or dislocation)
• spinal stenosis
• curvatures (i. i., scoliosis, kyphosis and/or lordosis)
• tumor
• pseudoarthrosis
• failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MOSS VRS System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions and is indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.

The MOSS VRS System consists of a variety of screws, polyaxial heads, rods, locking caps, connectors, hooks and associated general instruments. The implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to add components like additional polyaxial heads, cannulated screws, fenestrated screws, screws with larger diameters and lengths and hooks and connectors to the MOSS VRS Spinal System (see K181821).

The safety and effectiveness of the fenestrated screws has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

All implants of the MOSS VRS System are sinqle-use only and the system is provided non sterile.

The provided text is a 510(k) Summary for the MOSS VRS Spinal System. It details the device, its intended use, and the performance data for its substantial equivalence determination. However, it does not describe specific acceptance criteria with numerical thresholds or report the device's performance against such criteria in a detailed table format. Instead, it states that mechanical testing was performed to "support system related performance under consideration of well-established acceptance criteria" and that the "results demonstrate that the MOSS VRS Spinal System is substantially equivalent to the identified predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, nor can I provide specific details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.

Here's an overview of the information that is available related to performance, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (General Statement): The document states that testing was performed "under consideration of well-established acceptance criteria." However, it does not specify what those criteria are (e.g., "withstanding X N of force," "less than Y degrees of angular deformation," "surviving Z cycles").
• Reported Device Performance (General Statement): The document concludes that "The results demonstrate that the MOSS VRS Spinal System is substantially equivalent to the identified predicate devices." It does not provide numerical performance outcomes against specific benchmarks.

2. Sample Sized used for the test set and the data provenance:

• Missing: The document does not specify the sample size (number of constructs or tests) used for the mechanical bench testing.
• Data Provenance: The tests are "Bench testing - mechanical," indicating an engineered laboratory setting, not patient data (retrospective or prospective). The location of testing is not specified, but the manufacturer is based in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments) where expert consensus establishes a "ground truth." For mechanical bench testing, ground truth is based on physical measurements and engineering standards, not expert interpretation in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: As above, adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant to mechanical bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable: This document describes a spinal implant system and its mechanical testing for substantial equivalence, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: This document is not about an algorithm or AI device.

7. The type of ground truth used:

• Ground Truth: For mechanical testing, the "ground truth" is typically defined by the specified test methods (ASTM F1717 and ASTM F1798) and the physical properties and failure modes observed under controlled laboratory conditions, compared against the performance of predicate devices.
• Type: Engineering standards and physical measurements.

8. The sample size for the training set:

• Not Applicable: This document does not describe a machine learning algorithm or AI model, thus there is no "training set."

9. How the ground truth for the training set was established:

• Not Applicable: As there is no training set, this question is not relevant.

Summary of what is present:

• Study Type: Mechanical bench testing.
• Standards Used: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants).
• Tests Performed:
  • ASTM F1717: Static Compression, Dynamic Compression, Static Torsion.
  • ASTM F1798: Static Flexion Extension, Dynamic Flexion Extension, Static Axial Grip, Static Axial Pull-Off.
• Conclusion: The tests demonstrated that the MOSS VRS Spinal System is "substantially equivalent to the identified predicate devices."

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The MOSS VRS Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

• Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fractures or dislocations)
• Spinal Stenosis
• Curvatures (i.e. scoliosis, kyphosis and/ or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS system is indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. The MOSS VRS system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offers posterior clinical solutions. The MOSS VRS System is a universal set of instruments and implants that are indicated for the treatment of significant mechanical instability or deformity of the spine which requires fusion with instrumentation.

The MOSS VRS System provides several options for stabilization of the spine. Therefore, the system includes the following implants:

• Pedicle Screws Ø4.35-9mm, length 20-100mm
• Rods Ø5,5mm and Ø6,0mm, length 30-95mm, 120-600mm
• Locking Caps
• Polyaxial Reductionheads

The implants of the MOSS VRS System are single-use only and the system is provided non sterile.

This appears to be a 510(k) Summary for a medical device (MOSS VRS Spinal System). The document describes the device, its indications for use, and a comparison to predicate devices, including performance data. However, it does not describe a study involving an AI/Machine Learning device or specific acceptance criteria for such a device in the way your prompt requests.

The performance data section (8.1 Non-Clinical Test Summary) details bench testing for mechanical properties of the physical spinal implant system. It explicitly states, "No clinical tests were performed" (8.2 Clinical Test Summary).

Therefore, I cannot provide the requested information for an AI/ML device because this submission focuses on a traditional medical device (a spinal implant system) and its mechanical performance, not an AI-powered diagnostic or therapeutic tool.

If this document were for an AI/ML device, the requested information would typically be found in dedicated sections outlining the algorithm's performance study.

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